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Humanized Monoclonal Antibody (humanized + monoclonal_antibody)
Selected AbstractsRecent advances in the management and prophylaxis of respiratory syncytial virus infectionACTA PAEDIATRICA, Issue 2001A Greenough Respiratory syncytial virus (RSV) infection is an important cause of morbidity, particularly in prematurely born infants who have had chronic lung disease. Current therapy is essentially supportive. Overall, the results of randomized trials do not support the use of bronchodilators, corticosteroids or Ribavirin. Nitric oxide and exogenous surfactant may improve the respiratory status of those infants who require ventilatory support. Nosocomial infection can be reduced by appropriate handwashing. There is no safe and effective vaccine for use in infants. Immunoprophylaxis reduces hospitalization and requirement for intensive care. Palivizumab, a humanized monoclonal antibody, is preferred to RSV immune globulin as the immunoprophylactic agent. Immunoprophylaxis should be reserved for infants at highest risk of severe respiratory syncytial virus infection, if this strategy is to be used most cost-effectively. [source] Preserving , Cells in Type 1 Diabetes mellitus: the role of immunological toleranceDRUG DEVELOPMENT RESEARCH, Issue 3 2008Stanley R. Pillemer Abstract Type 1 diabetes mellitus (T1DM) is characterized by an autoimmune attack on beta cells of the islets of Langerhans. This immunological attack is mediated by effector T-lymphocytes and results in the destruction of the , cells. One approach to abrogating the immunological attack is to use immunosuppressive treatments. Such treatments tend to broadly suppress the immune system. A better approach is to develop treatments that induce tolerance. Autoimmune diseases are associated with the presence of inadequate numbers of functionally active regulatory T cells (Tregs). Tregs can induce a state of immunological tolerance and suppress the inflammation and destruction of target tissues. Teplizumab, also known as hOKT3,1 (Ala-Ala), is a humanized monoclonal antibody that induces Tregs. In clinical trials, treatment with this antibody preserved insulin production and improved metabolic control during the first year of T1DM. A pivotal multinational trial is in progress to determine the efficacy and safety of teplizumab in the treatment of new onset T1DM. Drug Dev Res 69:153,157, 2008. ©2008 Wiley-Liss, Inc. [source] Omalizumab (Xolair) in children with seasonal allergic rhinitis: Leukotriene release as a potential in vitro parameter to monitor therapeutic effectsPEDIATRIC ALLERGY AND IMMUNOLOGY, Issue 6 2007Matthias Volkmar Kopp To investigate the effect of omalizumab, a humanized monoclonal antibody, in addition to specific immunotherapy (SIT) on in vitro sulfidoleukotriene release (SLT) (A) before, (B) directly after, and (C) 1 yr after treatment with omalizumab. Children and adolescents (6.3,17.6 yr) with sensitization to birch and grass pollens and suffering from seasonal allergic rhinitis were included in a Phase III, placebo-controlled, multicenter clinical study. Within the four-arm study, patients were randomly chosen to receive SIT for either birch or grass pollen and either subcutaneous omalizumab or placebo for 24 wk during the pollen season. Thereafter, omalizumab or placebo treatment ended, but SIT therapy continued. Blood samples were collected from 92 (A, B) and 78 children (C), respectively. Leukocytes were isolated and stimulated with grass and birch pollen allergens. In the supernatants, SLT (LTC4, LTD4, LTE4) were measured using ELISA [cellular allergen stimulation test, DPC-Biermann, Germany]. At the end of treatment the combination of omalizumab + SIT-grass [median SLT-release: 2125 (before) and 416 ng/ml (after omalizumab treatment); p < 0.001] as well as omalizumab + SIT-birch [1404 and 207 ng/ml; p < 0.001] resulted in significantly lower SLT release after stimulation with the corresponding allergen compared to placebo + SIT-grass [2231 and 2490 ng/ml] or placebo + SIT-birch [1324 and 2489 ng/ml]. One year after omalizumab or placebo treatment, there was no significant difference in SLT release between the 4 groups (omalizumab + SIT-grass: 2855; SIT-grass + placebo: 2543; omalizumab + SIT-birch: 2417; SIT-birch + placebo: 2573 ng/ml). These results strongly suggest that the observed effects of decreased SLT release after omalizumab treatment were attributable to the treatment with omalizumab, rather than to SIT therapy. [source] Clinical Experience with Trastuzumab (Herceptin)THE BREAST JOURNAL, Issue 6 2003Charles L. Vogel MD Abstract: Trastuzumab is a humanized monoclonal antibody against the epidermal growth factor family oncogene, Her-2/neu. It has revolutionized therapy for the 15,20% of patients with metastatic breast cancer whose tumors have gene amplification for Her-2/neu. Results of clinical trials with single agent trastuzumab and in combination with paclitaxel, docetaxel, vinorelbine, gemcitabine and platinum salts have been encouraging. Durable remissions in excess of 5 years have occasionally been reported. Subjectively the side effect profile of this novel, targeted therapy, has been mild. Cardiac toxicity, while reported in combination regimens with anthracyclines tend to be easily manageable and not absolute contradictions to continuation of trastuzumab. Outside of clinical trials, however, anthracycline/trastuzumab combinations should be avoided. Preliminary results of trials with various combinations of chemotherapeutic agents have been promising while combinations with hormonal and other biologic therapy are ongoing. Trastuzumab is an exciting new monoclonal antibody with interesting anti-tumor activity in patients with Her-2/neu gene amplified breast cancer. We look forward to ongoing clinical trials combining trastuzumab with a broad array of other chemotherapeutic, hormonal and biological agents. [source] A phase I radioimmunolocalization trial of humanized monoclonal antibody huA33 in patients with gastric carcinomaCANCER SCIENCE, Issue 11 2006Junichi Sakamoto In order to determine the in vivo characteristics of huA33, an open label dose escalation biopsy-based phase I clinical trial and radioimmunolocalization study were conducted with a complement determinant region-grafted humanized monoclonal antibody against the A33 antigen in patients with gastric carcinoma. Thirteen patients were entered onto one of four dose levels (1.0, 2.0, 5.0 or 10.0 mg/m2). Patients with locally advanced (UICC-TNM [International Union Against Cancer,tumor, node, metastasis] stage over 2 but resectable at clinical diagnosis) gastric carcinoma received a single infusion of 131I-huA33 1 week prior to surgery. Adverse events were monitored, and imaging studies with gamma camera plus ex vivo scintigraphy of the resected specimen, biodistribution study by dosimetry analysis of the biopsied and resected tissues, and immunohistochemical analysis were carried out and evaluated. No dose-limiting toxicity was observed during the trial. Therefore, the maximum tolerated dose was not reached. Although cancer tissues with + intensity and <25% extent by immunostaining in biopsied frozen sections did not show positive imaging or postoperative dosimetry findings, cancers with ++ or +++ intensity or wide (>25%) extent by frozen and paraffin sections in the biopsied specimen showed positive ex vivo tumor images and positive antigen expression in resected gastric cancer specimens, and the biodistribution analysis showed tumor uptake of 131I-huA33. In conclusion, humanized monoclonal antibody huA33 demonstrated selective localization to gastric cancer that expressed A33 antigen strongly. These excellent targeting characteristics of huA33 indicate potential for targeted therapy of advanced gastric cancer that is refractory to cytotoxic therapy, and could also be exploitable for curatively resected early gastric cancer in an adjuvant setting. (Cancer Sci 2006; 97: 1248,1254) [source] | ||||||||||